# K250747: Globe® Pulsed Field System

- Pathway: 510(k) (Traditional)
- Applicant: Kardium, Inc.
- Decided: Jun 25, 2025 after 105 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K001437 (2000). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241828: Affera Integrated Mapping System; Impedance Localization Patch Kit, Medtronic, Inc. (2024) Summary page 5.

## Indications for use
The Globe PF System is indicated for catheter-based cardiac anatomical and electrophysiological mapping and stimulation of cardiac tissue.

Source page: https://510kreport.com/device/K250747
Methodology: https://510kreport.com/methodology